Pfizer, BioNTech Granted Authorization for COVID-19 Vaccine in the European Union

The announcement came hours after the companies disclosed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion to authorize the vaccine.

Pfizer and BioNTech announced Monday that the European Commission (EC) has granted a conditional marketing authorization (CMA) for their vaccine against the coronavirus disease 2019 (COVID-19). The CMA is valid in all 27 member states of the European Union (EU).1

The announcement came hours after the companies disclosed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion to authorize the vaccine, BNT162b2, which will be marketed as Comirnaty, for individuals aged 16 and older.1,2

“The [CMA] by the [EC] is a historic achievement. It is the first vaccine which has been developed in a large-scale trial with more than 44,000 participants and approved in less than a year to address this pandemic. This is based on the decade-long pioneering work by many scientists from all over the world,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech, in a prepared statement. “We are looking forward to delivering the vaccine to Europeans in the upcoming days. We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalized.”1

According to the companies, distribution of the vaccine by the EU member states will be determined according to the populations identified in EU and national guidance.1

The EU authorization is based on the totality of scientific evidence shared by the companies as part of the EMA’s rolling review process and the application for CMA, which the companies submitted on December 1, 2020. This included data from a pivotal Phase 3 clinical study that demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection—the virus that causes COVID-19—the first primary objective, and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. According to Pfizer and BioNTech, the Data Monitoring Committee or the study has not reported safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored to assess the duration of efficacy and safety for an additional 2 years after their second dose.1

“With the pandemic still raging in many countries, we are continuing to work around the clock to bring this vaccine to the world as quickly, efficiently and equitably as possible,” said Albert Bourla, Chairman and chief executive officer, Pfizer, in a prepared statement. “We are grateful that this authorization is bringing hope to people across the continent, as we hopefully turn the corner of this crisis and approach the new year.”1

Following today’s CMA, Pfizer and BioNTech will initiate delivery of the first vaccine doses immediately across the EU based on a distribution plan defined by the EC and contract terms. Pfizer and BioNTech reached an agreement with the EC in November to supply 200 million doses of a vaccine for COVID-19 in 2020 and 2021, with the option for up to 100 million additional doses, subject to agreement of the involved parties.1

According to the companies, delivery of BNT162b2 will begin immediately, and occur in stages, throughout 2020 and 2021. Vaccine doses for Europe will be produced in BioNTech’s manufacturing sites in Germany, and Pfizer’s manufacturing site in Puurs, Belgium.1

To date, the BNT162b2 vaccine has been authorized or approved for emergency use in more than 15 countries. Regulatory reviews are underway in several countries, with more submissions anticipated.2

This vaccine has not been approved or licensed by the FDA, but was granted an Emergency Use Authorization (EUA) by the agency for use in individuals aged 16 years and older in the United States. The emergency use of this product is only authorized by the FDA for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product.2

Although BNT162b2 was the first vaccine against COVID-19 to receive the FDA’s EUA designation, the agency has also granted EUA status to Moderna’s COVID-19 vaccine, mRNA-1273.3

REFERENCES

  • Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine [news release]. New York, NY, and Mainz, Germany; December 21, 2020: Pfizer. Accessed December 21, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-authorization-european-union
  • Pfizer and BioNTech Receive CHMP Positive Opinion for Their COVID-19 Vaccine [news release]. New York, NY, and Mainz, Germany; December 21, 2020: Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-chmp-positive-opinion-their
  • Coppock K. FDA Grants Emergency Use to Moderna COVID-19 Vaccine. Pharmacy Times®. Published December 18, 2020. Accessed December 21, 2020. https://www.pharmacytimes.com/news/fda-grants-emergency-use-to-moderna-covid-19-vaccine